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Monday, October 19, 2009

The Amgen team must have felt rather bullish that the FDA would approve denosumab today, since it is the PDUFA date. So they loaded this link on the biotech’s web site for anyone seeking information on reimbursement issues. [UPDATE: Amgen has removed the page and we didn't take a screengrab, but we have the new logo, below.UPDATE 2: Here's the page, rescued by commenter rob using Google cache.]

Never mind that it was still possible the agency would issue a complete response letter, which would cause a delay. And sure enough, that’s just what happened. The agency is requesting several items, including more detail about a post-marketing surveillance program (see the statement).

Reimbursement info is rather important to place on web sites, of course, given that more and more people are having difficulty affording their meds, especially during the recession. So this is a good public relations move, not just a genuinely helpful gesture. Pricing for denosumab, which Amgen has dubbed Prolia, is expected to cost about $1,000 a month, according to earlier reports, although that may change.

In any event, this isn’t the first time that Amgen has somehow gotten ahead of the FDA over a drug approval. In July 2008, BusinessWire issued a press release saying the agency had approved the Nplate blood clotting drug, albeit with certain risk management requirements. But the premature release embarrassed Amgen, which forced the news service to issue a retraction.

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